HOPKINTON, Mass., April 16, 2007 /PRNewswire-FirstCall/ -- Boston Life Sciences announced today that clinical data on its lead nerve repair therapy, Cethrin(R), were presented in the Neurotrauma and Critical Care Scientific Session at the 75th Annual Meeting of the American Association of Neurological Surgeons (AANS) in Washington, DC.
The oral presentation, "Results of the Cethrin Phase I/IIa Prospective Clinical Trial of a Rho Inhibitor for the Treatment of Acute Spinal Cord Injury," was given by Michael G. Fehlings, MD, PhD, FRC, Medical Director of the Krembil Neuroscience Center and Head of the Spinal Program at the University Health Network of the University of Toronto and principle investigator in the study. Co-authors are Nicholas Theodore, MD, James Harrop, MD, Gilles Maurais, MD, Charles Kuntz, MD, Christopher Shaffrey, MD, Brian Kwon, MD, Jens Chapman, MD, Albert Yee, MD, Patrick Tremblay, PhD, and Lisa McKerracher, PhD.
"The preliminary results in this study show that Cethrin may offer great promise for restoring sensory and motor function for patients with new cases of acute SCI," stated Dr. Mark Hurtt, BLSI's Chief Medical Officer. "We have extended the Phase IIa trial to include a 9 mg dose. Currently, three patients have been enrolled at this level and we expect the enrollment at this dosage extension to continue to the 3rd quarter of 2007. Additionally, based on the positive findings to-date in the Phase I/II trial, we are drafting a protocol for a Phase IIb/III study. We plan to meet with the FDA and with Health Canada and plan to initiate this trial in North America by the end of this year or early 2008."
Thirty-seven patients with acute SCI were enrolled in the open
label study at nine sites across Canada and the United States. All
patients were classified with a complete SCI assessed as American